System for deploying a resistive shape memory catheterization device and methods for use therewith

ABSTRACT

A system for deploying a shape memory catheterization device within a patient, includes a catheter for endovascular insertion of the shape memory catheterization device. A heat source heats the shape memory catheterization device above the transition temperature. A transformation data generator includes a circuit driver for driving a circuit that includes at least one resistive element of the shape memory catheterization device and a detection circuit for generating transformation data based on a resistance of the at least one resistive element, wherein the transformation data indicates a shape transformation of the shape memory catheterization device from a catheterization shape to a transformed shape.

CROSS REFERENCE TO RELATED PATENTS

The present U.S. Utility patent application claims priority pursuant to35 U.S.C. § 120 as a continuation of U.S. Utility application Ser. No.13/956,501, entitled “SYSTEM FOR DEPLOYING A RESISTIVE SHAPE MEMORYCATHETERIZATION DEVICE AND METHODS FOR USE THEREWITH”, filed Aug. 1,2013, which claims priority pursuant to 35 U.S.C. § 119(e) to U.S.Provisional Application No. 61/754,473, entitled “SHAPE MEMORYCATHETERIZATION DEVICE WITH ELECTRICAL TRANSFORMATION FEEDBACK ANDMETHODS FOR USE THEREWITH”, filed Jan. 18, 2013, both of which arehereby incorporated herein by reference in their entirety and made partof the present U.S. Utility patent application for all purposes.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT DISC

Not Applicable

BACKGROUND OF THE INVENTION Technical Field of the Invention

This invention relates generally to medical devices that intravenouslyinsert shape memory members in a patient.

Description of Related Art

A wide range of medical treatments can be performed with a catheter thatis intravenously inserted in a patient. Such catheterizations havereduced invasiveness compared with conventional treatments leading tolower risk to the patient, faster healing times, etc. Shape memorydevices that change shape based on temperature have been used in suchcatheterizations. These devices can be lightweight and biocompatible.

The disadvantages of conventional approaches will be evident to oneskilled in the art when presented the disclosure that follows.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods of operationthat are further described in the following Brief Description of theDrawings, the Detailed Description of the Invention, and the claims.Other features and advantages of the present invention will becomeapparent from the following detailed description of the invention madewith reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1 is a schematic block diagram of an embodiment of a system fordeploying a shape memory catheterization device 98 in accordance withthe present invention;

FIG. 2 is a schematic block diagram of an embodiment of a system fordeploying a shape memory catheterization device 98 in accordance withthe present invention;

FIG. 3 is a graphical representation of a temperature profile of inaccordance with an embodiment the present invention;

FIG. 4 is a flow diagram of an embodiment of a method in accordance withthe present invention;

FIG. 5 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention;

FIG. 6 is a graphical representation of a resistance profile of inaccordance with an embodiment the present invention;

FIG. 7 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention;

FIG. 8 is a graphical representation of a capacitance profile of inaccordance with an embodiment the present invention;

FIG. 9 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention;

FIG. 10 is a graphical representation of inductance profile of inaccordance with an embodiment the present invention;

FIG. 11 is a schematic block diagram of an embodiment of a drivercircuit 112 and detection circuit 114 in accordance with the presentinvention;

FIG. 12 is a graphical representation of a strain profile of inaccordance with an embodiment the present invention;

FIG. 13 is a pictorial representation of the shape transformation of ashape memory member of in accordance with an embodiment the presentinvention;

FIG. 14 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 15 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 16 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 17 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 18 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 19 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 20 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention;

FIG. 21 is a pictorial representation of a shape memory member andcatheter in accordance with an embodiment the present invention;

FIG. 22 is a pictorial representation of a shape memory member andcatheter in accordance with an embodiment the present invention;

FIG. 23 is a pictorial representation of a shape memory member andcatheter in accordance with an embodiment the present invention;

FIG. 24 is a flowchart representation of an embodiment of a method inaccordance with the present invention;

FIG. 25 is a flowchart representation of an embodiment of a method inaccordance with the present invention;

FIG. 26 is a flowchart representation of an embodiment of a method inaccordance with the present invention;

FIG. 27 is a flowchart representation of an embodiment of a method inaccordance with the present invention;

FIG. 28 is a flowchart representation of an embodiment of a method inaccordance with the present invention;

FIG. 29 is a flowchart representation of an embodiment of a method inaccordance with the present invention; and

FIG. 30 is a flowchart representation of an embodiment of a method inaccordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is a schematic block diagram of an embodiment of a system fordeploying a shape memory catheterization device 98 in accordance withthe present invention. In particular, a shape memory catheterizationdevice 98 includes a catheter having a delivery rod 150 for use inconjunction with a catheterization procedure involving the insertion ofthe shape memory catheterization device 98 into a patient. Examples ofsuch catheterization procedures include the insertion of an endovascularstent as part of an angioplasty or treatment of an aneurism or theintravenous deployment of another medical device, an intravenous drugdeployment or the administration of anesthetic medication into theepidural space, the subarachnoid space, or around a major nerve bundlesuch as the brachial plexus, the administration of anesthetic medicationinto the epidural space, the subarachnoid space, or around a major nervebundle such as the brachial plexus, an in vitro fertilization or othermedical treatment, a urinary catheterization, treatment of an abdominalabscess, a balloon septostomy, balloon sinuplasty, catheter ablation, anin vitro fertilization or other medical treatment.

The shape memory catheterization device 98 includes a shape memorymember 100 having a transition temperature that is higher than a normalbody temperature of the patient. When heat is applied by a heat source104 the shape memory member 100 of shape memory catheterization device98 is heated above the transition temperature causes the shape memorymember 100 to undergo a shape transformation from a catheterizationshape into a transformed shape that is useful in the particulartreatment. The heat source 104 can be an infrared emitter, laser orother light source, a heating coil or other electrical heating source, amicrowave source or other electromagnetic source, a radiation source orother heat source. While shown separately from the shape memorycatheterization device 98, the heat source 104 can be integrated intothe shape memory catheterization device 98.

A transformation data generator 102 includes a circuit driver 112 fordriving a circuit that includes at least one electrical element of theshape memory member 100 via a signal line included in the delivery rodand a plurality of electrodes that couple to the shape memory device100. The transformation data generator 102 also includes a detectioncircuit 114 for generating transformation data 106 based on feedbackgenerated by the detection circuit 114. The transformation data 106indicates a shape transformation of the shape memory member 100 of theshape memory catheterization 98 device from the catheterization shape tothe transformed shape. In an embodiment of the present invention thetransformation data 106 can be displayed or otherwise used to providevisual, audible or tactile feedback to the users of shape memorycatheterization device 98 that the shape memory member 100 has reachedits transformation shape.

Further examples including numerous optional functions and features ofshape memory catheterization device 98 are discussed in conjunction withFIGS. 2-30 that follow.

FIG. 2 is a schematic block diagram of an embodiment of a system fordeploying a shape memory catheterization device 98 in accordance withthe present invention. In particular, a system is shown that includesmany common elements of those described in conjunction with FIG. 1 thatare referred to by common reference numerals. In addition, a heatingcontrol generator 110 is included that generates a control signal 108for controlling the heat source 104 based on the transformation data106. In operation, the heating control generator generates the controlsignal 108 to discontinue the heating of the shape memorycatheterization device 98 when the transformation data 106 indicates theshape transformation of the shape memory member 100 from thecatheterization shape to the transformed shape.

In an example of operation, the shape memory member 100 is a shapememory polymer, alloy or other device with a transition temperature thatis slightly above the body temperature of the patient. The shape memorymember 100 is heated above the transition temperature to effectuate theshape transformation of the shape memory member as part of thetreatment. Overheating of blood or tissue can cause undesirable bloodclotting during a treatment or other harmful effects. Discontinuingheating by heat source 104 after the shape transformation has occurredcan avoid overheating the patient's tissue, blood and other body fluidsduring the procedure and allows the users of shape memorycatheterization device to provide only as much heat as is reasonablynecessary to effectuate the shape transformation.

Heating control generator 110 can be implemented using a processingdevice such as shared processing device, individual processing devices,or a plurality of processing devices and may further include memory.Such a processing device may be a microprocessor, micro-controller,digital signal processor, microcomputer, central processing unit, fieldprogrammable gate array, programmable logic device, state machine, logiccircuitry, digital circuitry, and/or any device that manipulates signalsbased on operational instructions. The memory may be a single memorydevice or a plurality of memory devices. Such a memory device may be aread-only memory, random access memory, volatile memory, non-volatilememory, static memory, dynamic memory, flash memory, and/or any devicethat stores digital information. Note that when the processing deviceimplements one or more of its functions via a state machine, digitalcircuitry, and/or logic circuitry, the memory storing the correspondingoperational instructions is embedded with the circuitry comprising thestate machine, digital circuitry, and/or logic circuitry.

FIG. 3 is a graphical representation of a temperature profile inaccordance with an embodiment of the present invention. In particular, atemperature profile is presented of a shape memory member, such as shapememory member 100. The shape memory member can be a shape memory polymersuch as a cold hibernated elastic memory (CHEM) polymer or other shapememory polymer, shape memory alloy or other shape memory device. Asshown, the elastic modulus, E, of the shape memory member 100 changesbased on whether the temperature, T, of the shape memory member is aboveor below a transition temperature, T_(t). For the range of temperaturesT<T_(t), the elastic modulus is high and the shape memory member isrigid and holds a particular shape. For the range of temperaturesT>T_(t), the elastic modulus is low and the shape memory member isflexible. Consider the example where the shape memory member 100 is ashape memory polymer that has a transition temperature, T_(t), thatcorresponds to a glass transition. For the range of temperaturesT<T_(t), the shape memory member is in a glassy state and is rigid. Forthe range of temperatures T>T_(t), the shape memory member is in arubbery state and the shape memory member is flexible. This property ofthe shape memory member can be used to create a heat induced shapetransformation as described in conjunction with FIG. 4.

FIG. 4 is a flow diagram of an embodiment of a method in accordance withthe present invention. In step 120, a shape memory member, such as shapememory member 100 of shape memory catheterization device 98, is heatedabove its transition temperature and enters a flexible state. In step122, the shape memory member is deformed from an original shape into itscatheterization shape. In step 124, the shape memory member is cooledwhile constrained to its catheterization shape, and becomes rigid,allowing it to retain its deformed catheterization shape when theconstraint is removed. In step 126, the shape memory member is heatedduring catheterization for deployment as part of the catheterizationtreatment. When the shape memory member reenters the rubbery state, theshape memory member undergoes a shape transformation back to itsoriginal shape.

As shown in step 128, the shape transformation of the shape memorymember 100 is detected based on transformation data, such astransformation data 106 generated by the transformation data generator104. As discussed in conjunction with FIG. 1, the transformation data106 can be displayed or otherwise used to provide visual, audible ortactile feedback to the users of shape memory catheterization device 98that the shape memory member 100 has reached its transformation shape.As discussed in conjunction with FIG. 2, the transformation data can beused by a heating control generator to generate the control signal 108to discontinue the heating of the shape memory member 100 when thetransformation data indicates the shape transformation of the shapememory member has gone from the catheterization shape to the transformedshape. If the shape memory member 100 is a stent or other device that isto remain in the body, the cooling of the shape memory member back tothe body temperature of the patient causes the shape memory member toreturn to its rigid state to hold the transformed shape.

FIG. 5 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention.In this embodiment, the shape memory member 100 includes a resistiveelement that has a resistance R_(sm) that changes in response to theshape transformation of the shape memory member. For example, the shapememory member 100 can be a shape memory polymer with electricallyresistive properties, that is surface doped with a conductive orpartially conductive compound, or that is doped to saturation with aconductive or partially conductive compound. In a further example theshape memory member can be formed of a shape memory polymer to include aflexible resistive member such as a metallic foil element adhered ordeposited on the surface of the shape memory member, a flexible foil orcoil insert, a resistive foam member or insert or other resistivemember. In addition, the shape memory member can be formed of a shapememory alloy that is electrically conductive with a resistance thatchanges in response to the shape transformation of the shape memorymember 100.

The driver circuit includes a power source, such as the voltage sourceshown, that drives the detection circuit 114 and a wheatstone bridgeformed with the resistive element of the shape memory member 100 and aplurality of fixed resistors. The voltage detector 105 monitors thechange in resistance of the resistive element of shape memory member 100and generates the transformation data 104, for example, when the changein resistance R_(sm) indicates that the shape transformation hasoccurred.

In an embodiment, the voltage detector 105 generates the transformationdata 106 to indicate the shape transformation of the shape memory memberfrom the catheterization shape to the transformed shape when theresistance R_(sm) of the resistive element compares favorably to atransformation threshold. In particular, the transformation data 106 caninclude a data flag having a first value that indicates thecatheterization shape and a second value that indicates the transformedshape. The transition of the transformation data 106 from the firstvalue to the second value can indicate that the transformation hasoccurred.

FIG. 6 is a graphical representation of a resistance profile of inaccordance with an embodiment the present invention. An exampleresistance profile of a resistive element of shape memory member 100 isshown. As the shape memory member is heated in conjunction with thedeployment of the shape memory catheterization device, the resistance,R_(sm) changes with time. In particular, the resistance R_(sm) changesin response to the shape transformation of the shape memory member 100caused by the heating of the shape memory catheterization device.

As discussed in conjunction with FIG. 5, the voltage detector 105generates the transformation data 106 to indicate the shapetransformation of the shape memory member 100 from the catheterizationshape to the transformed shape when the resistance R_(sm) of theresistive element compares favorably to a transformation threshold. Inthe example shown, the transformation over time of the shape memorymember causes the resistance R_(sm) to increase. At a time, T₁, theresistance R_(sm) reaches a transition threshold, R_(tt), and stabilizesindicating the shape transformation is complete. In this example thevoltage detector can include a comparator that generates thetransformation data 106 when the R_(sm) meets or exceeds the transitionthreshold, R_(tt).

While the transformation over time of the shape memory member causes theresistance R_(sm) to increase in the example shown, in other examples,the resistance may decrease depending on the nature of the original andcatheterization shape of the shape memory member and/or the nature,position and orientation of the resistive element or elements includedin the shape memory member 100, etc. Further, while the voltage detectorhas been described in terms of comparing the resistance R_(sm) to atransition threshold, R_(tt). other metrics such as the stabilization ofthe resistance R_(sm) can likewise be employed.

Further, while the embodiments above contemplate a shape memory device100 with a single resistive element, multiple resistive elements can bedriven and monitored by transformation data generator 102. For example,resistive elements can be placed at multiple points, on multiple axes oftransformation or otherwise on multiple portions of a shape memorymember 100. In this configuration, transformation data 106 can begenerated to indicate the transform shape when all of the resistiveelements indicate a transformation has taken place.

FIG. 7 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention.In this embodiment, the shape memory member 100 includes a capacitiveelement that has a capacitance C_(sm) that changes in response to theshape transformation of the shape memory member. For example, the shapememory member 100 can be a shape memory polymer with capacitiveproperties, that is includes a plurality of plates that are surfacedoped with a conductive or partially conductive compound, a metallicfoil element adhered or deposited on the surface of the shape memorymember or a conductive foam or other conductive element that forms theplates. The shape memory polymer further includes an electrolytic,dielectric or insulator made of a shape memory polymer that is disposedbetween the plurality of plates. In addition, the shape memory membercan be formed of a shape memory alloy that is electrically conductivewith a capacitance such as a parasitic capacitance that changes inresponse to the shape transformation of the shape memory member 100.

The driver circuit 112 includes a power source, such as the voltagesource shown, that drives the detection circuit 114 via an alternatingcurrent such as the step waveform generator that is shown. The drivercircuit further includes a detection resistance R_(d) that forms an RCcircuit with the capacitive element of the shape memory member 100. Thevoltage detector 105 monitors the change in capacitance of thecapacitive element of shape memory member 100 based on monitoring thetime of charging and/or discharging of the capacitive element. Thevoltage detector generates the transformation data 104, for example,when the change in capacitance C_(sm) indicates that the shapetransformation has occurred.

In an embodiment, the voltage detector 105 generates the transformationdata 106 to indicate the shape transformation of the shape memory memberfrom the catheterization shape to the transformed shape when thecapacitance C_(sm) of the capacitive element compares favorably to atransformation threshold. In particular, the transformation data 106 caninclude a data flag having a first value that indicates thecatheterization shape and a second value that indicates the transformedshape. The transition of the transformation data 106 from the firstvalue to the second value can indicate that the transformation hasoccurred.

FIG. 8 is a graphical representation of a capacitance profile of inaccordance with an embodiment the present invention. An examplecapacitance profile of a capacitive element of shape memory member 100is shown. As the shape memory member 100 is heated in conjunction withthe deployment of the shape memory catheterization device, thecapacitance, C_(sm), changes with time. In particular, the capacitanceC_(sm) changes in response to the shape transformation of the shapememory member caused by the heating of the shape memory catheterizationdevice.

As discussed in conjunction with FIG. 7, the voltage detector 105generates the transformation data 106 to indicate the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape when the capacitance C_(sm) of the capacitiveelement compares favorably to a transformation threshold. In the exampleshown, the transformation over time of the shape memory member causesthe capacitance C_(sm) to increase. At a time, T₁, the capacitanceC_(sm) reaches a transition threshold, C_(tt), and stabilizes indicatingthe shape transformation is complete. In this example the voltagedetector can include a comparator that generates the transformation data106 when the C_(sm) meets or exceeds the transition threshold, C_(tt).

While the transformation over time of the shape memory member causes thecapacitance C_(sm) to increase in the example shown, in other examples,the capacitance may decrease depending on the nature of the original andcatheterization shape of the shape memory member and/or the nature,position and orientation of the capacitive element or elements includedin the shape memory member, etc. Further, while the voltage detector hasbeen described in terms of comparing the capacitance C_(sm) to atransition threshold, C_(tt). other metrics such as the stabilization ofthe capacitance C_(sm) can likewise be employed.

Further, while the embodiments above contemplate a shape memory devicewith a single capacitive element, multiple capacitive elements can bedriven and monitored by transformation data generator 102. For example,capacitive elements can be placed at multiple points, on multiple axesof transformation or otherwise on multiple portions of a shape memorymember 100. In this configuration, transformation data 106 can begenerated to indicate the transformation shape when all of thecapacitive elements indicate a transformation has taken place.

FIG. 9 is a schematic block diagram of an embodiment of a driver circuit112 and detection circuit 114 in accordance with the present invention.In this embodiment, the shape memory member 100 includes an inductiveelement that has an inductance L_(sm) that changes in response to theshape transformation of the shape memory member. For example, the shapememory member can be a shape memory polymer with electrically inductiveproperties, that is surface doped with a conductive or partiallyconductive compound, or that is doped to saturation with a conductive orpartially conductive compound. In a further example the shape memorymember can be formed of a shape memory polymer to include a flexibleinductive member such as a metallic foil element adhered or deposited onthe surface of the shape memory member, a flexible foil or coil insert,a conductive foam member or insert or other inductive member. Inaddition, the shape memory member can be formed of a shape memory alloythat is electrically conductive with an inductance that changes inresponse to the shape transformation of the shape memory member 100.

The driver circuit 112 includes a power source, such as the voltagesource shown, that drives the detection circuit 114 via an alternatingcurrent such as the step waveform generator that is shown. The drivercircuit further includes a detection resistance R_(d) that forms an RLcircuit with the inductive element of the shape memory member 100. Thevoltage detector 105 monitors the change in inductance of the inductiveelement of shape memory member 100 based on monitoring the time ofcharging and/or discharging of the inductive element. The voltagedetector generates the transformation data 104, for example, when thechange in inductance L_(sm) indicates that the shape transformation hasoccurred.

In an embodiment, the voltage detector 105 generates the transformationdata 106 to indicate the shape transformation of the shape memory memberfrom the catheterization shape to the transformed shape when theinductance L_(sm) of the inductive element compares favorably to atransformation threshold. In particular, the transformation data 106 caninclude a data flag having a first value that indicates thecatheterization shape and a second value that indicates the transformedshape. The transition of the transformation data from the first value tothe second value can indicate that the transformation has occurred.

FIG. 10 is a graphical representation of an inductance profile of inaccordance with an embodiment the present invention. An exampleinductance profile of an inductive element of shape memory member 100 isshown. As the shape memory member is heated in conjunction with thedeployment of the shape memory catheterization device, the inductance,L_(sm), changes with time. In particular, the inductance L_(sm) changesin response to the shape transformation of the shape memory membercaused by the heating of the shape memory catheterization device.

As discussed in conjunction with FIG. 9, the voltage detector 105generates the transformation data 106 to indicate the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape when the inductance L_(sm) the inductiveelement compares favorably to a transformation threshold. In the exampleshown, the transformation over time of the shape memory member causesthe inductance L_(sm) to increase. At a time, T₁, the inductance L_(sm)reaches a transition threshold, L_(tt), and stabilizes indicating theshape transformation is complete. In this example the voltage detectorcan include a comparator that generates the transformation data 106 whenthe inductance L_(sm) meets or exceeds the transition threshold, L_(tt).

While the transformation over time of the shape memory member causes theinductance L_(sm) to increase in the example shown, in other examples,the inductance may decrease depending on the nature of the original andcatheterization shape of the shape memory member and/or the nature,position and orientation of the inductive element or elements includedin the shape memory member, etc. Further, while the voltage detector hasbeen described in terms of comparing the inductance L_(sm) to atransition threshold, L_(tt). other metrics such as the stabilization ofthe inductance L_(sm) can likewise be employed.

Further, while the embodiments above contemplate a shape memory devicewith a single inductive element, multiple inductive elements can bedriven and monitored by transformation data generator 102. For exampleinductive elements can be placed at multiple points, on multiple axes oftransformation or otherwise on multiple portions of a shape memorymember 100. In this configuration, transformation data 106 can begenerated to indicate the transform shape when all of the inductiveelements indicate a transformation has taken place.

FIG. 11 is a schematic block diagram of an embodiment of a drivercircuit 112 and detection circuit 114 in accordance with the presentinvention. In this embodiment, the shape memory member 100 includes astrain gage that has a resistance R_(sm) that changes in response tostrain on the shape memory member 100. For example, the shape memorymember 100 can be a shape memory polymer or other shape memory memberwith a strain gage adhered or deposited on the surface of the shapememory member. In particular, strain and corresponding resistance R_(sm)change with the shape transformation of the shape memory member 100.

The driver circuit includes a power source, such as the voltage sourceshown, that drives the detection circuit 114, and a wheatstone bridgeformed with the resistive element R_(sm) of the strain gage of shapememory member 100 and a plurality of fixed resistors. The voltagedetector 105 monitors the change in strain of the strain gage bymonitoring the resistance of strain gage and generates thetransformation data 104, for example, when the change in resistanceR_(sm) indicates that the shape transformation has occurred.

In an embodiment, the voltage detector 105 generates the transformationdata 106 to indicate the shape transformation of the shape memory memberfrom the catheterization shape to the transformed shape when theresistance R_(sm) (corresponding to the strain of the strain gage)compares favorably to a transformation threshold. In particular, thetransformation data 106 can include a data flag having a first valuethat indicates the catheterization shape and a second value thatindicates the transformed shape. The transition of the transformationdata from the first value to the second value can indicate that thetransformation has occurred.

FIG. 12 is a graphical representation of a strain profile of inaccordance with an embodiment the present invention. An example strainprofile of a strain gage of shape memory member 100 is shown. As theshape memory member is heated in conjunction with the deployment of theshape memory catheterization device, the strain, S_(sm), changes withtime. In particular, the strain S_(sm) changes in response to the shapetransformation of the shape memory member caused by the heating of theshape memory catheterization device.

As discussed in conjunction with FIG. 11, the voltage detector 105generates the transformation data 106 to indicate the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape when the resistance R_(sm) corresponding to thestrain S_(sm) of the strain gage compares favorably to a transformationthreshold. In the example shown, the transformation over time of theshape memory member causes the strain S_(sm) to increase. At a time, T₁,the strain S_(sm) reaches a transition threshold, S_(tt), and stabilizesindicating the shape transformation is complete. In this example thevoltage detector can include a comparator that generates thetransformation data 106 when the S_(sm) meets or exceeds the transitionthreshold, S_(tt).

While the transformation over time of the shape memory member causes thestrain S_(sm) to increase in the example shown, in other examples, thestrain may decrease depending on the nature of the original andcatheterization shape of the shape memory member and/or the nature,position and orientation of the strain gage or gages included in theshape memory member, etc. Further, while the voltage detector has beendescribed in terms of comparing the strain S_(sm) to a transitionthreshold, S_(tt). other metrics such as the stabilization of the strainS_(sm) can likewise be employed.

Further, while the embodiments above contemplate a shape memory devicewith a single strain gage, multiple strain gages can be driven andmonitored by transformation data generator 102. For example, straingages can be placed at multiple points, on multiple axes oftransformation or otherwise on multiple portions of a shape memorymember 100. In this configuration, transformation data 106 can begenerated to indicate the transform shape when all of the strain gagesindicate a transformation has taken place.

FIG. 13 is a pictorial representation of the shape transformation of ashape memory member of in accordance with an embodiment the presentinvention. In particular, a shape memory member 100 is presented as acylinder. Examples of such shape memory members include a cylindricaltube constructed with shape memory polymer for grafting a vein or arteryto treat an aneurism or a cylindrical tube constructed with shape memorypolymer or cylindrical mesh constructed with either a shape memorypolymer or shape memory alloy for supporting a vein or artery afterremoving a blockage. In the configuration shown, the shape memory member100 is fitted on a delivery rod to be delivered through a delivery rod150 (a portion of which is shown schematically) and is deformed from anoriginal shape 120 into a catheterization shape 122 with reduceddiameter via crimping. When the shape memory member 100 is heated duringdeployment, it transforms into the transformed shape 124 that issubstantially the original shape 120, subject to, for example, physicalconformity to the tissue, such as the vein, artery or other tissue inwhich the shape memory catheterization device is deployed.

While the catheterization shape 122 is shown as cylindrical, othershapes are possible including a flattened cylinder, and other shapes,based on the particular method of deformation and further based on thedesired shape for catheterization. Further, while the original shape 120is shown as cylindrical, other regular geometrical shapes such asspherical, pyramidal, etc. could likewise be employed as well as anynumber of irregular shapes, based on the desired shape for deployment ofthe shape memory member 100.

It should be noted that the shape memory member 100 can be detached fromthe delivery rod 150 after being placed in the proper tissue locationfor deployment and left in the patient. In embodiments where the shapememory member 100 includes a shape memory polymer, the shape memorypolymer can be doped with a drug, such as an anticoagulant to reducingclotting, a drug to promote acceptance of the device by the surroundingtissue or other drug.

FIG. 14 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.In particular, a shape memory member 100 is presented as a cylinder.Examples of such shape memory members include a cylindrical cup forholding a drug for intravenous deployment. In the configuration shown,the closed end of the cup is fitted to a delivery rod 150, (the end ofwhich is shown schematically) and the inner portion of the cup is packedwith the drug to be deployed via the open end 121 and is then deformedfrom an original shape 120 into a catheterization shape 123 viacrimping. As shown the open end 121 of the original shape 120 is closedin the catheterization shape 123 to hold the drug for catheterization ina pocket 125 for deployment. When the shape memory member 100 is heatedduring deployment, it transforms into transformed shape 124 that issubstantially the original shape 120, subject to, for example, physicalconformity to the tissue, such as the vein, artery or other tissue inwhich the shape memory device is deployed. The end 121 of the cup opensfor release of the drug.

While the catheterization shape 122 is shown as cylindrical, othershapes are possible including a flattened cylinder, and other shapes,based on the particular method of deformation and further based on thedesired shape for catheterization. Further, while the original shape 120is shown as cylindrical, other regular geometrical shapes such asspherical, pyramidal, etc. could likewise be employed as well as anynumber of irregular shapes, based on the desired shape for deployment ofthe shape memory member.

It should be noted that the shape memory member 100 can remain attachedto the delivery rod 150 after being placed in the proper tissue locationfor deployment and removed from the patient after the drug is released.In embodiments where the shape memory member includes a shape memorypolymer, the shape memory polymer can also be doped with a drug, such asan anticoagulant to reducing clotting, or other drug.

FIG. 15 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.In particular, a shape memory member 100 is presented as a cylinder.Examples of such shape memory members include a cylindrical with aspherical pocket 126 for holding a drug for intravenous deployment. Inthe configuration shown, the cylinder is fitted to a delivery rod 150,(the end of which is shown schematically) and the pocket 126 is packedwith the drug to be deployed and is then deformed from an original shape125 into a catheterization shape 127 via crimping a portion of thecylinder shown. As shown, the pocket 126 of the original shape 125 isclosed in the catheterization shape 127 to hold the drug forcatheterization in a pocket 126 for deployment. When the shape memorymember 100 is heated during deployment, it transforms into transformedshape 129 that is substantially the original shape 125, subject to, forexample, physical conformity to the tissue, such as the vein, artery orother tissue in which the shape memory device is deployed. The pocket126 opens for release of the drug.

While the catheterization shape 127 is shown as cylindrical, othershapes are possible including a flattened cylinder, and other shapes,based on the particular method of deformation and further based on thedesired shape for catheterization. Further, while the original shape 125is shown as cylindrical, other regular geometrical shapes such as aspherical, pyramidal, etc. could likewise be employed as well as anynumber of irregular shapes, based on the desired shape for deployment ofthe shape memory member. In a further embodiment, the shape memorymember can be a hollow cup that is crimped to hold the ball end of amedical device and that releases the ball end for deployment. Further,while a single pocket 126 is shown, a shape memory member 100 withmultiple pockets could be implemented in a similar fashion.

It should be noted that the shape memory member 100 can remain attachedto the delivery rod 150 after being placed in the proper tissue locationfor deployment and removed from the patient after the drug is released.Delivery rod 150 includes a plurality of electrodes 130 and 132 thatelectrically couple to the shape memory member 100. In operation, theelectrodes couple a transformation data generator 110 to a capacitive,resistive element or an inductive element of shape memory member 100 ora strain gage coupled thereto. The plurality of electrodes areelectrically coupled to a portion of the shape memory member 100 todetect a change in resistance, capacitance or inductance of the shapememory member caused by the shape transformation of the shape memorymember 100 during deployment.

The plurality of electrodes 130 and 132 can be formed of a biocompatiblewire or foil such as gold or other biocompatible metal or metal alloy, ashape memory polymer with electrically conductive properties, such as ashape memory polymer that is surface doped with a conductive compound.In a further example the plurality of electrodes 130 and 132 can beformed a flexible conductive foam member or insert or other conductivemember.

In embodiments where the shape memory member 100 includes a shape memorypolymer, the shape memory polymer can also be doped with a drug, such asan anticoagulant to reducing clotting, or other drug. While a particularmedical device is shown, other medical devices can similarly deployed.Further, while the medical device is shown with a ball end, other catchdesigns including a pyramidal catch, a box catch or other shapes canlikewise be implemented

FIG. 16 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.In particular, a shape memory member 100 is shown along with electrodes130 and 132 that electrically couple to the shape memory member. Theelectrodes can be part of a delivery rod such as delivery rod 150, notspecifically shown.

In various embodiments, the shape memory member 100 can be detached fromthe delivery rod 150 after being placed in the proper tissue locationfor deployment and left in the patient. In these embodiments, theplurality of electrodes 130 and 132 decouple from the shape memorymember 100 when the shape memory member 100 is detached from thedelivery rod 150. In embodiments where the shape memory member 100remains attached to the delivery rod and is removed from the patient'sbody after treatment the electrodes 130 and 132 can be more permanentlyattached to the shape memory member 100.

In operation, the electrodes couple a transformation data generator 110to a resistive element or an inductive element of shape memory member100. As previously discussed, the shape memory member can be a shapememory polymer with electrically resistive or inductive properties, thatis surface doped with a conductive or partially conductive compound, orthat is doped to saturation with a conductive or partially conductivecompound. In a further example the shape memory member can be formed ofa shape memory polymer to include a flexible resistive or inductivemember such as a metallic foil element adhered or deposited on thesurface of the shape memory member, a flexible foil or coil insert, aresistive foam member or insert or other resistive or inductive member.In addition, the shape memory member can be formed of a shape memoryalloy that is electrically conductive with either a resistance orinductance that changes in response to the shape transformation of theshape memory member 100.

The plurality of electrodes 130 and 132 can be formed of a biocompatiblewire or foil such as gold or other biocompatible metal or metal alloy, ashape memory polymer with electrically conductive properties, such as ashape memory polymer that is surface doped with a conductive compound.In a further example the plurality of electrodes 130 and 132 can beformed a flexible conductive foam member or insert or other conductivemember.

FIG. 17 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.As in the embodiment of FIG. 16, a shape memory member 100 is shownalong with electrodes 130 and 132 that electrically couple to the shapememory member. In this embodiment, the electrodes couple atransformation data generator 110 to a capacitive element of shapememory member 100 via conductive plates 134 and 136. The plates 134 and136 can be constructed of metallic foil elements adhered or deposited onthe surface of the shape memory member, conductive foam members orinserts or other conductive member. The shape memory element 100 can bedoped with an electrolytic compound to increase the capacitance of thedevice.

FIG. 18 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.As in the embodiment of FIGS. 16 and 17, a shape memory member 100 isshown along with electrodes 130 and 132 that electrically couple to theshape memory member. In this embodiment, the electrodes couple atransformation data generator 110 to a strain gage 136 of shape memorymember 100. The strain gage can be constructed of metallic foil elementsadhered or deposited on the surface of the shape memory member,conductive foam members or inserts or other strain gage configurations.

FIG. 19 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.In particular, a shape memory member 100 is presented as a coil.Examples of such shape memory members include a coil constructed withshape memory alloy or shape memory polymer for to treat an aneurism byfilling a weakened portion of a vein or artery. In the configurationshown, the shape memory member 100 is fitted on a catheter (not shown)and is deformed from an original shape 140 into a catheterization shape142. When the shape memory member 100 is heated during deployment, ittransforms into transformed shape 144 that is substantially the originalshape 140, subject to, for example, physical conformity to the tissue,such as the vein, artery or other tissue in which the shape memorycatheterization device is deployed.

The shape memory member 100 can be constructed of a resistive orconductive wire or other resistive or conductive material that isbiocompatible. The shape transformation of the shape memory member 100can be detected based on a change of resistance or inductance of theshape memory member.

It should be noted that the shape memory member 100 can be detached fromthe delivery rod 150 after being placed in the proper tissue locationfor deployment and left in the patient. In embodiments where the shapememory member includes a shape memory polymer, the shape memory polymercan be doped with a drug, such as an anticoagulant to reducing clotting,a drug to promote acceptance of the device by the surrounding tissue orother drug.

FIG. 20 is a pictorial representation of the transformation of a shapememory member of in accordance with an embodiment the present invention.In particular, a shape memory member 100 is presented as a cylinder.Examples of such shape memory members include a cylinder with aspherical pocket 126 for holding a medical device 146 such as a coil forintravenous deployment for treatment of an aneurism.

In the configuration shown, the shape memory member 100 is fitted to adelivery rod 150, (the end of which is shown schematically) and thepocket 126 is packed with a catch, such as a ball end of the medicaldevice 146 to be deployed. The shape memory device 100 is then deformedfrom an original shape 145 into a catheterization shape 147 via crimpinga portion of the cylinder shown. As shown, the pocket 146 of theoriginal shape 145 is closed in the catheterization shape 147 to holdthe ball end medical device for catheterization in the pocket 126 fordeployment. When the shape memory member 100 is heated duringdeployment, it transforms into transformed shape 149 that issubstantially the original shape 125, subject to, for example, physicalconformity to the tissue, such as the vein, artery or other tissue inwhich the shape memory device is deployed. The pocket 126 opens forrelease of the medical device 146. In the embodiment shown, the medicaldevice 146 is itself constructed of a shape memory member, such as ashape memory wire, alloy or polymer that is compressed into acatheterization shape and that expands to its own transformed shape fortreatment.

While the catheterization shape 147 is shown as cylindrical, othershapes are possible including a flattened cylinder, and other shapes,based on the particular method of deformation and further based on thedesired shape for catheterization. Further, while the original shape 145is shown as cylindrical, other regular geometrical shapes such asspherical, pyramidal, etc. could likewise be employed as well as anynumber of irregular shapes, based on the desired shape for deployment ofthe shape memory member. Further, while a single pocket 146 is shown, ashape memory member 100 with multiple pockets could be implemented in asimilar fashion.

It should be noted that the shape memory member 100 can remain attachedto the delivery rod 150 after being placed in the proper tissue locationfor deployment and removed from the patient after the medical device 146is released. Delivery rod 150 includes a plurality of electrodes 130 and132 that electrically couple to the shape memory member 100. Inoperation, the electrodes couple a transformation data generator 110 toa capacitive, resistive element or an inductive element of shape memorymember 100 or a strain gage coupled thereto. The plurality of electrodesare electrically coupled to a portion of the shape memory member 100 todetect a change in resistance, capacitance or inductance of the shapememory member caused by the shape transformation of the shape memorymember 100 during deployment.

The plurality of electrodes 130 and 132 can be formed of a biocompatiblewire or foil such as gold or other biocompatible metal or metal alloy, ashape memory polymer with electrically conductive properties, such as ashape memory polymer that is surface doped with a conductive compound.In a further example the plurality of electrodes 130 and 132 can beformed a flexible conductive foam member or insert or other conductivemember.

In embodiments where the shape memory member 100 includes a shape memorypolymer, the shape memory polymer can also be doped with a drug, such asan anticoagulant to reducing clotting, or other drug.

FIGS. 21 and 22 present pictorial representations of a shape memorymember and delivery rod in accordance with an embodiment the presentinvention. Like the embodiment of FIG. 19, a shape memory member 100 ispresented as a coil such as a coil constructed with shape memory alloyor shape memory polymer for to treat an aneurism by filling a weakenedportion of a vein or artery. In the configuration shown, the shapememory member 100 is fitted on a delivery rod 150 and is deformed froman original shape shown in FIG. 21 into a catheterization shape shown inFIG. 22. When the shape memory member 100 is heated during deployment,it transforms into transformed shape that is substantially the originalshape, subject to, for example, physical conformity to the tissue, suchas the vein, artery or other tissue in which the shape memorycatheterization device is deployed.

It should be noted that the shape memory member 100 can be detached fromthe delivery rod 150 after being placed in the proper tissue locationfor deployment and left in the patient. Delivery rod 150 includes aplurality of electrodes 130 and 132 that electrically couple to theshape memory member 100 and that decouple from the shape memory member100 when the shape memory member 100 is detached from the delivery rod150. In operation, the electrodes couple a transformation data generator110 to a capacitive, resistive element or an inductive element of shapememory member 100 or a strain gage coupled thereto. The plurality ofelectrodes 130 and 132 are electrically coupled to a portion of theshape memory member 100 to detect a change in resistance, capacitance orinductance of the shape memory member caused by the shape transformationof the shape memory member 100 during deployment.

The plurality of electrodes 130 and 132 can be formed of a biocompatiblewire or foil such as gold or other biocompatible metal or metal alloy, ashape memory polymer with electrically conductive properties, such as ashape memory polymer that is surface doped with a conductive compound.In a further example, the plurality of electrodes 130 and 132 can beformed a flexible conductive foam member or insert or other conductivemember. It should be noted that the shape memory member 100 can bedetached from the delivery rod 150 and electrodes 130 and 132 afterbeing placed in the proper tissue location for deployment and left inthe patient.

FIG. 23 is a pictorial representation of a shape memory member andcatheter in accordance with an embodiment the present invention. Inparticular, a cross section is shown of a cylindrical shape memorymember 100 and electrodes 130 and 132. In this embodiment the electrodesare arc shaped to conform with the outer surface of the cylindricalshape memory member 100. While each electrode 130 or 132 is shown as asingle homogeneous element, each electrode can include a central palmand a plurality of fingers each having a longitudinal axis along thelongitudinal axis of the cylindrical shape memory member 100. In thisconfiguration, the fingers of each electrode lend themselves to beingcrimped into a position of contact when the shape memory member 100 isdeformed for catheterization and to remain in contact with the shapememory member 100 when the shape memory member 100 undergoes its shapetransformation.

FIG. 24 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-23. Step 400 includes endovascularinsertion of the shape memory member via a catheter, wherein the shapememory member has a transition temperature that is higher than a normalbody temperature of the patient. Step 402 includes heating the shapememory member above the transition temperature. Step 404 includesdriving a circuit that includes at least one resistive element of theshape memory member. Step 406 includes generating transformation databased on a resistance of the at least one resistive element, wherein thetransformation data indicates a shape transformation of the shape memorycatheterization device from a catheterization shape to a transformedshape.

In an embodiment, the transformation data is generated to indicate theshape transformation of the shape memory member from the catheterizationshape to the transformed shape when the resistance of the at least oneresistive element compares favorably to a transformation threshold. Thetransformation data can includes a data flag having a first value thatindicates the catheterization shape and a second value that indicatesthe transformed shape.

The shape memory catheterization device can include an endovascularstent for treating a blocked artery, an endovascular stent for treatingan arterial aneurism. The shape memory catheterization device canintravenously deploy a drug or a medical device in response to the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape. The shape memory member can be doped tointravenously deploy a drug.

FIG. 25 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-24. Step 410 includes generating acontrol signal for controlling the heat source based on thetransformation data. In an embodiment, a control signal is generated todiscontinue the heating of the shape memory member when thetransformation data indicates the shape transformation of the shapememory member from the catheterization shape to the transformed shape.

FIG. 26 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-25. Step 420 includes endovascularinsertion of the shape memory member via a delivery rod through acatheter, wherein the shape memory member has a transition temperaturethat is higher than a normal body temperature of the patient. Step 422includes heating the shape memory member above the transitiontemperature. Step 424 includes driving a circuit that includes at leastone capacitive element of the shape memory member. Step 426 includesgenerating transformation data based on a capacitance of the at leastone capacitive element, wherein the transformation data indicates ashape transformation of the shape memory member from a catheterizationshape to a transformed shape.

In an embodiment, the transformation data is generated to indicate theshape transformation of the shape memory member from the catheterizationshape to the transformed shape when the capacitance of the at least onecapacitive element compares favorably to a transformation threshold. Thetransformation data can includes a data flag having a first value thatindicates the catheterization shape and a second value that indicatesthe transformed shape.

The shape memory catheterization device can include an endovascularstent for treating a blocked artery, an endovascular stent for treatingan arterial aneurism. The shape memory catheterization device canintravenously deploy a drug or a medical device in response to the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape. The shape memory member can be doped tointravenously deploy a drug.

FIG. 27 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-26. Step 430 includes endovascularinsertion of a shape memory member via a delivery rod through acatheter, wherein the shape memory member has a transition temperaturethat is higher than a normal body temperature of the patient. Step 432includes heating the shape memory member above the transitiontemperature. Step 434 includes driving a circuit that includes at leastone inductive element of the shape memory member. Step 436 includesgenerating transformation data based on an inductance of the at leastone inductive element, wherein the transformation data indicates a shapetransformation of the shape memory member from a catheterization shapeto a transformed shape.

In an embodiment, the transformation data is generated to indicate theshape transformation of the shape memory member from the catheterizationshape to the transformed shape when the inductance of the at least oneinductive element compares favorably to a transformation threshold. Thetransformation data can includes a data flag having a first value thatindicates the catheterization shape and a second value that indicatesthe transformed shape.

The shape memory catheterization device can include an endovascularstent for treating a blocked artery, an endovascular stent for treatingan arterial aneurism. The shape memory catheterization device canintravenously deploy a drug or a medical device in response to the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape. The shape memory member can be doped tointravenously deploy a drug.

FIG. 28 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-27. Step 440 includes endovascularinsertion of the shape memory member via a delivery rod through acatheter, wherein the shape memory member has a transition temperaturethat is higher than a normal body temperature of the patient. Step 442includes heating the shape memory member above the transitiontemperature. Step 444 includes driving a circuit that includes at leastone strain gage coupled to the shape memory member. Step 446 includesgenerating transformation data based on a strain indicated by the atleast one strain gage, wherein the transformation data indicates a shapetransformation of the shape memory member from a catheterization shapeto a transformed shape.

In an embodiment, the transformation data is generated to indicate theshape transformation of the shape memory member from the catheterizationshape to the transformed shape when the strain indicated by the at leastone strain gage element compares favorably to a transformationthreshold. The transformation data can includes a data flag having afirst value that indicates the catheterization shape and a second valuethat indicates the transformed shape.

The shape memory catheterization device can include an endovascularstent for treating a blocked artery, an endovascular stent for treatingan arterial aneurism. The shape memory catheterization device canintravenously deploy a drug or a medical device in response to the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape. The shape memory member can be doped tointravenously deploy a drug.

FIG. 29 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-28. Step 450 includes endovascularinsertion of a shape memory member via a delivery rod through acatheter, wherein the shape memory member has a transition temperaturethat is higher than a normal body temperature of the patient and whereinthe catheter includes a plurality of electrodes that are crimped forelectrical coupling to the shape memory member during transformation ofthe shape memory member from an original shape into a catheterizationshape. Step 452 includes heating the shape memory member above thetransition temperature. Step 454 includes electrically driving a circuitthat includes an element of the shape memory member coupled via theplurality of electrodes. Step 456 includes generating transformationdata in response to the circuit, wherein the transformation dataindicates a shape transformation of the shape memory member from thecatheterization shape to a transformed shape.

In an embodiment, the circuit is electrically driven by either a directcurrent or an alternative current. The shape memory catheterizationdevice can include an endovascular stent for treating a blocked arteryor an endovascular stent for treating an arterial aneurism. The shapememory catheterization device can intravenously deploy a drug inresponse to the shape transformation of the shape memory member from thecatheterization shape to the transformed shape. The shape memorycatheterization device can intravenously deploy a drug. The shape memorycatheterization device can intravenously deploy a medical device inresponse to the shape transformation of the shape memory member from thecatheterization shape to the transformed shape. The transformation datacan include a data flag having a first value that indicates thecatheterization shape and a second value that indicates the transformedshape.

FIG. 30 is a flowchart representation of an embodiment of a method inaccordance with the present invention. In particular, a method ispresented for use in conjunction with one or more features and functionsdescribed in conjunction with FIGS. 1-29. Step 460 includes heating ashape memory member above a transition temperature of the shape memorymember, wherein the transition temperature that is higher than a normalbody temperature of the patient. Step 462 includes crimping a pluralityof electrodes of a catheter for electrical coupling to the shape memorymember during transformation of the shape memory catheterization devicefrom an original shape into a catheterization shape, while the shapememory catheterization device is above the transition temperature.

The shape memory catheterization device can include an endovascularstent for treating a blocked artery or an endovascular stent fortreating an arterial aneurism. The shape memory catheterization devicecan intravenously deploy a drug in response to the shape transformationof the shape memory member from the catheterization shape to thetransformed shape. The shape memory catheterization device canintravenously deploy a drug. The shape memory catheterization device canintravenously deploy a medical device in response to the shapetransformation of the shape memory member from the catheterization shapeto the transformed shape.

As may be used herein, the terms “substantially” and “approximately”provides an industry-accepted tolerance for its corresponding termand/or relativity between items. Such an industry-accepted toleranceranges from less than one percent to fifty percent and corresponds to,but is not limited to, component values, integrated circuit processvariations, temperature variations, rise and fall times, and/or thermalnoise. Such relativity between items ranges from a difference of a fewpercent to magnitude differences. As may also be used herein, theterm(s) “operably coupled to”, “coupled to”, and/or “coupling” includesdirect coupling between items and/or indirect coupling between items viaan intervening item (e.g., an item includes, but is not limited to, acomponent, an element, a circuit, and/or a module) where, for indirectcoupling, the intervening item does not modify the information of asignal but may adjust its current level, voltage level, and/or powerlevel. As may further be used herein, inferred coupling (i.e., where oneelement is coupled to another element by inference) includes direct andindirect coupling between two items in the same manner as “coupled to”.As may even further be used herein, the term “operable to” or “operablycoupled to” indicates that an item includes one or more of powerconnections, input(s), output(s), etc., to perform, when activated, oneor more its corresponding functions and may further include inferredcoupling to one or more other items. As may still further be usedherein, the term “associated with”, includes direct and/or indirectcoupling of separate items and/or one item being embedded within anotheritem. As may be used herein, the term “compares favorably”, indicatesthat a comparison between two or more items, signals, etc., provides adesired relationship. For example, when the desired relationship is thatsignal 1 has a greater magnitude than signal 2, a favorable comparisonmay be achieved when the magnitude of signal 1 is greater than that ofsignal 2 or when the magnitude of signal 2 is less than that of signal1.

As may also be used herein, the terms “processing module”, “processingcircuit”, and/or “processing unit” may be a single processing device ora plurality of processing devices. Such a processing device may be amicroprocessor, micro-controller, digital signal processor,microcomputer, central processing unit, field programmable gate array,programmable logic device, state machine, logic circuitry, analogcircuitry, digital circuitry, and/or any device that manipulates signals(analog and/or digital) based on hard coding of the circuitry and/oroperational instructions. The processing module, module, processingcircuit, and/or processing unit may be, or further include, memoryand/or an integrated memory element, which may be a single memorydevice, a plurality of memory devices, and/or embedded circuitry ofanother processing module, module, processing circuit, and/or processingunit. Such a memory device may be a read-only memory, random accessmemory, volatile memory, non-volatile memory, static memory, dynamicmemory, flash memory, cache memory, and/or any device that storesdigital information. Note that if the processing module, module,processing circuit, and/or processing unit includes more than oneprocessing device, the processing devices may be centrally located(e.g., directly coupled together via a wired and/or wireless busstructure) or may be distributedly located (e.g., cloud computing viaindirect coupling via a local area network and/or a wide area network).Further note that if the processing module, module, processing circuit,and/or processing unit implements one or more of its functions via astate machine, analog circuitry, digital circuitry, and/or logiccircuitry, the memory and/or memory element storing the correspondingoperational instructions may be embedded within, or external to, thecircuitry comprising the state machine, analog circuitry, digitalcircuitry, and/or logic circuitry. Still further note that, the memoryelement may store, and the processing module, module, processingcircuit, and/or processing unit executes, hard coded and/or operationalinstructions corresponding to at least some of the steps and/orfunctions illustrated in one or more of the Figures. Such a memorydevice or memory element can be included in an article of manufacture.

The present invention has been described above with the aid of methodsteps illustrating the performance of specified functions andrelationships thereof. The boundaries and sequence of these functionalbuilding blocks and method steps have been arbitrarily defined hereinfor convenience of description. Alternate boundaries and sequences canbe defined so long as the specified functions and relationships areappropriately performed. Any such alternate boundaries or sequences arethus within the scope and spirit of the claimed invention. Further, theboundaries of these functional building blocks have been arbitrarilydefined for convenience of description. Alternate boundaries could bedefined as long as the certain significant functions are appropriatelyperformed. Similarly, flow diagram blocks may also have been arbitrarilydefined herein to illustrate certain significant functionality. To theextent used, the flow diagram block boundaries and sequence could havebeen defined otherwise and still perform the certain significantfunctionality. Such alternate definitions of both functional buildingblocks and flow diagram blocks and sequences are thus within the scopeand spirit of the claimed invention. One of average skill in the artwill also recognize that the functional building blocks, and otherillustrative blocks, modules and components herein, can be implementedas illustrated or by discrete components, application specificintegrated circuits, processors executing appropriate software and thelike or any combination thereof.

The present invention may have also been described, at least in part, interms of one or more embodiments. An embodiment of the present inventionis used herein to illustrate the present invention, an aspect thereof, afeature thereof, a concept thereof, and/or an example thereof. Aphysical embodiment of an apparatus, an article of manufacture, amachine, and/or of a process that embodies the present invention mayinclude one or more of the aspects, features, concepts, examples, etc.described with reference to one or more of the embodiments discussedherein. Further, from figure to figure, the embodiments may incorporatethe same or similarly named functions, steps, modules, etc. that may usethe same or different reference numbers and, as such, the functions,steps, modules, etc. may be the same or similar functions, steps,modules, etc. or different ones.

Unless specifically stated to the contra, signals to, from, and/orbetween elements in a figure of any of the figures presented herein maybe analog or digital, continuous time or discrete time, and single-endedor differential. For instance, if a signal path is shown as asingle-ended path, it also represents a differential signal path.Similarly, if a signal path is shown as a differential path, it alsorepresents a single-ended signal path. While one or more particulararchitectures are described herein, other architectures can likewise beimplemented that use one or more data buses not expressly shown, directconnectivity between elements, and/or indirect coupling between otherelements as recognized by one of average skill in the art.

The term “unit”, also referred to as a “module”, is used in thedescription of the various embodiments of the present invention. Amodule includes a processing module, a functional block, hardware,and/or software stored on memory for execution by a processing devicethat performs one or more functions as may be described herein. Notethat, if the module is implemented via hardware, the hardware mayoperate independently and/or in conjunction software and/or firmware. Asused herein, a module may contain one or more sub-modules, each of whichmay be one or more modules.

While particular combinations of various functions and features of thepresent invention have been expressly described herein, othercombinations of these features and functions are likewise possible. Thepresent invention is not limited by the particular examples disclosedherein and expressly incorporates these other combinations.

What is claimed is:
 1. A system comprising: a shape memorycatheterization device having a transition temperature that is higherthan a normal body temperature of a patient; a catheter having adelivery rod configured to endovascularly insert the shape memorycatheterization device in the patient; a heat source configured to heatthe shape memory catheterization device above the transitiontemperature, wherein heating the shape memory catheterization deviceabove the transition temperature causes the shape memory catheterizationdevice to undergo a shape transformation from a catheterization shape toa transformed shape, and further causes a change in a resistance of theshape memory catheterization device as a result of the shapetransformation; and a transformation data generator, coupled to thecatheter, that includes a circuit driver configured to drive a detectioncircuit that monitors the change in the resistance of the shape memorycatheterization device and to generate transformation data based on thechange in the resistance of the shape memory catheterization deviceresulting from the shape transformation of the shape memorycatheterization device.
 2. The system of claim 1 further comprising: aheating control generator, coupled to the transformation data generatorand the heat source, the heating control generator generating a controlsignal for controlling the heat source based on the transformation data.3. The system of claim 2 wherein the heating control generator generatesthe control signal to discontinue the heating of the shape memorycatheterization device when the transformation data indicates the shapetransformation of the shape memory catheterization device from thecatheterization shape to the transformed shape.
 4. The system of claim 1wherein the shape memory catheterization device is doped with one of: aconductive compound or a partially conductive compound.
 5. The system ofclaim 1 wherein the shape memory catheterization device includes anendovascular stent for treating a blocked artery.
 6. The system of claim1 wherein the shape memory catheterization device includes anendovascular stent for treating an arterial aneurism.
 7. The system ofclaim 1 wherein the shape memory catheterization device intravenouslydeploys a drug in response to the shape transformation of the shapememory catheterization device from the catheterization shape to thetransformed shape.
 8. The system of claim 1 wherein the shape memorycatheterization device intravenously deploys a drug.
 9. The system ofclaim 1 wherein the shape memory catheterization device intravenouslydeploys a medical device in response to the shape transformation of theshape memory catheterization device from the catheterization shape tothe transformed shape.
 10. The system of claim 1 wherein the change inthe resistance of the shape memory catheterization device results fromthe change in the resistance of a resistive member as a result of theshape transformation of the shape memory catheterization device, whereinthe resistive member is an integral part of the shape memorycatheterization device, and wherein the resistive member is one of: ametallic foil element, a coil insert, or a resistive foam element.
 11. Amethod comprising: endovascularly inserting, via a catheter having adelivery rod, a shape memory catheterization device into a patient, theshape memory catheterization device having a transition temperature thatis higher than a normal body temperature of the patient; heating, via aheat source, the shape memory catheterization device above thetransition temperature, wherein heating the shape memory catheterizationdevice above the transition temperature causes the shape memorycatheterization device to undergo a shape transformation from acatheterization shape to a transformed shape, and further causes achange in a resistance of the shape memory catheterization device as aresult of the shape transformation; driving, via a driving circuit, adetection circuit that monitors the change in the resistance of theshape memory catheterization device; and generating, via the detectioncircuit, transformation data based on the change in the resistance ofthe shape memory catheterization device resulting from the shapetransformation of the shape memory catheterization device.
 12. Themethod of claim 11 further comprising: generating, via a heating controlgenerator, a control signal for controlling the heat source based on thetransformation data.
 13. The method of claim 12 wherein the heatingcontrol generator generates the control signal to discontinue theheating of the shape memory catheterization device when thetransformation data indicates the shape transformation of the shapememory catheterization device from the catheterization shape to thetransformed shape.
 14. The method of claim 11 wherein the shape memorycatheterization device is doped with one of: a conductive compound or apartially conductive compound.
 15. The method of claim 11 wherein theshape memory catheterization device includes an endovascular stent fortreating a blocked artery.
 16. The method of claim 11 wherein the shapememory catheterization device includes an endovascular stent fortreating an arterial aneurism.
 17. The method of claim 11 wherein theshape memory catheterization device intravenously deploys a drug inresponse to the shape transformation of the shape memory catheterizationdevice from the catheterization shape to the transformed shape.
 18. Themethod of claim 11 wherein the shape memory catheterization deviceintravenously deploys a drug.
 19. The method of claim 11 wherein theshape memory catheterization device intravenously deploys a medicaldevice in response to the shape transformation of the shape memorycatheterization device from the catheterization shape to the transformedshape.
 20. The method of claim 11 wherein the change in the resistanceof the shape memory catheterization device results from the change inthe resistance of a resistive member as a result of the shapetransformation of the shape memory catheterization device, wherein theresistive member is an integral part of the shape memory catheterizationdevice, and wherein the resistive member is one of: a metallic foilelement, a coil insert, or a resistive foam element.